Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001340729
Ethics application status
Approved
Date submitted
4/12/2013
Date registered
9/12/2013
Date last updated
7/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two doses of citrate in regional citrate anticoagulation during hemodialysis
Scientific title
Comparison of biocompatibility markers with two doses of citrate in regional citrate anticoagulation during hemodialysis
Secondary ID [1] 283684 0
None
Universal Trial Number (UTN)
U1111-1148-0399
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemodialysis
 290648 0
kidney disease 290649 0
Condition category
Condition code
Renal and Urogenital 291027 291027 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single, 4 hour hemodialysis with regional citrate anticoagulation with citrate dose 60 mmol/h
Intervention code [1] 288386 0
Treatment: Other
Comparator / control treatment
Single, 4 hour hemodialysis with regional citrate anticoagulation with citrate dose 40 mmol/h
Control group
Dose comparison

Outcomes
Primary outcome [1] 291015 0
Increase in thrombin-antitrombin complex (TAT, human ELISA kit), normalised to hematocrit before dialysis
Timepoint [1] 291015 0
during 4 hour dialysis
Secondary outcome [1] 305844 0
Increase in complement fragment C5a (human ELISA kit), normalised to hematocrit before dialysis
Timepoint [1] 305844 0
after 30 minutes of dialysis
Secondary outcome [2] 305845 0
increase in plasma platelet factor 4 (PF4), normalised to hematocrit before dialysis
Timepoint [2] 305845 0
during 4 hour dialysis
Secondary outcome [3] 305846 0
increase in plasma myeloperoxidaze (MPO), normalised to hematocrit before dialysis
Timepoint [3] 305846 0
during 4 hour dialysis
Secondary outcome [4] 305847 0
pre-filter ionized calcium, measured with ion-selective electrode ionometer
Timepoint [4] 305847 0
30 minutes and 240 minutes after starting hemodialysis

Eligibility
Key inclusion criteria
adult patients, needing hemodialysis
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
acute illness, acute bleeding, known malignancy, current infection, immunosuppressive or anticoagulant therapy, known intolerance to citrate anticoagulation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
12/01/2018
Date of last participant enrolment
Anticipated
Actual
21/05/2018
Date of last data collection
Anticipated
Actual
22/05/2018
Sample size
Target
30
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 5661 0
Slovenia
State/province [1] 5661 0

Funding & Sponsors
Funding source category [1] 288371 0
Government body
Name [1] 288371 0
Javna agencija za raziskovallno dejavnost RS
Country [1] 288371 0
Slovenia
Primary sponsor type
Hospital
Name
University Medical Center Ljubljana
Address
Zaloska 7
1000 Ljubljana
Country
Slovenia
Secondary sponsor category [1] 287076 0
None
Name [1] 287076 0
Address [1] 287076 0
Country [1] 287076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290253 0
National medical ethics committee
Ethics committee address [1] 290253 0
prof. Joze Trontelj
Inst. za klinicno nevrofiziologijo
UKC LJubljana
Zaloska 7
1000 LJubljana
Ethics committee country [1] 290253 0
Slovenia
Date submitted for ethics approval [1] 290253 0
04/03/2013
Approval date [1] 290253 0
19/03/2013
Ethics approval number [1] 290253 0
89/03/13

Summary
Brief summary
To compare markers of biocompatibility with two different doses of citrate in hemodialysis with regional citrate anticoagulation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42882 0
Dr Jakob Gubensek
Address 42882 0
University Medical Center Ljubljana
Dept. of nephrology
Zaloska 7
1000 Ljubljana
Country 42882 0
Slovenia
Phone 42882 0
+386 1 522 3112
Fax 42882 0
Email 42882 0
[email protected]
Contact person for public queries
Name 42883 0
Dr Jakob Gubensek
Address 42883 0
University Medical Center Ljubljana
Dept. of nephrology
Zaloska 7
1000 Ljubljana
Country 42883 0
Slovenia
Phone 42883 0
+386 1 522 3112
Fax 42883 0
Email 42883 0
[email protected]
Contact person for scientific queries
Name 42884 0
Dr Jakob Gubensek
Address 42884 0
University Medical Center Ljubljana
Dept. of nephrology
Zaloska 7
1000 Ljubljana
Country 42884 0
Slovenia
Phone 42884 0
+386 1 522 3112
Fax 42884 0
Email 42884 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWebiocompatibility parameters with standard and increased dose of citrate in hemodialysis-a randomized trial.2021https://dx.doi.org/10.3390/jcm10132987
N.B. These documents automatically identified may not have been verified by the study sponsor.